Sunday, December 26, 2010

Getting Ready For 2011 @ Hepatitis C New Drugs

Good Afternoon Folks,

I hope you had a great Holiday! With Christmas behind us and a new year on the way the importance of this virus, liver health and treating Hepatitis C will continue to take precedence on this little blog.

New hope is currently in the works with the FDA process in full swing for the approval of telaprevir. Following close behind is boceprevir, with a number of other protease inhibitors now in various stages of testing.
The dream we all share is for future HCV therapy to be successful without interferon and ribavirin. We can only hope the extremely brutal 48-week regime of peginterferon and ribavirin ; "which only cured about 40 percent to 50 percent of people with genotype 1", will soon be considered the dinosaur of HCV therapy, and with that, die out. The promise of shorter treatment duration is upon us, however, because the virus becomes rapidly resistant to telaprevir it will be used in combination with SOC (peginterferon and ribavirin). The dream of treating without SOC will have to wait. I am grateful we will soon have telaprevir in our arsenal; with the drugs ability to achieve a higher cure rate *SVR across all genotypes.
Back in March of 2010 excitement grew with the news of two oral inhibitors being tested for the treatment of HCV. Telaprevir and VX-222 combination was to begin a trial with and without SOC. The thought of treating without peginterferon and ribavirin was too good to be true, and maybe it was.
In October of this year the VX-222/telaprevir combo being tested in low doses was stopped because of viral breakthrough. Just recently in a higher dose of the VX-222/telaprevir combo was halted in part of the Vertex study. However, testing of the two drugs in other combination therapies will continue.
Quoted From Vertex ;
"This trial has provided important information regarding telaprevir and VX-222-based combination regimens, and three of the five treatment arms are proceeding as planned," said Robert Kauffman, senior vice president and chief medical officer for Vertex. "We are pleased with the progress of both four-drug treatment arms and look forward to the first quarter of 2011 when on-treatment data from these arms will become available and enrollment in the three-drug treatment arm is expected to begin.
The other (non-interferon drug combo) is the HCV Polymerase Inhibitor RG7128 plus the Protease Inhibitor Danoprevir =(ITMN-191/RG7227 ) which suppresses HCV Viral Load without Interferon or Ribavirin.
On April 25, 2009, Roche, InterMune, Inc., and Pharmasset announced the first results from the initial study of an interferon-free regimen for the treatment of patients chronically infected with HCV.
Read More Here......
The bottom line is we will have to wait before treating HCV without peginterferon and ribavirin.
As mentioned above the good news is Vertex has completed its NDA on telaprevir. Telaprevir has been deemed the "New blockbuster treatment for HCV ", for now.

Let's sum up the data folks

For All Those People Treating For The First Time With Telaprevir and SOC.
The Stats: From The Phase Three Advance Study
Treating for the first time with geno 1 ; has a cure rate of 75%.

Shorter Treatment Duration ?

In the ADVANCE trial the data showed treatment duration for most of the patients who were on a 12-week course of the "telaprevir combination" were able to shorten the total length of treatment from 48 weeks to 24 weeks.
In the advance study only about 9% who achieved SVR relapsed, as their HCV levels became detectable at post-treatment follow-up.

As for the difficult to cure patients

The Data from the REALIZE trial which included: Relapser, Partial Responder, and Null Responder

REALIZE is the only Phase 3 study to date of a direct-acting antiviral medicine to include all three major subgroups of people with hepatitis C who did not achieve a viral cure with a previous course of therapy:

• Relapser: defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period;

• Partial Responder: defined as a person who achieved at least a 2 log10 (100 times) reduction in viral load (HCV RNA) at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy

• Null Responder: defined as a person who experienced a less than 2 log10 drop in viral load at week 12 of a prior course of therapy.

Pivotal study in 662 people who did not achieve a viral cure with previous therapy.

The Stats: REALIZE Trial
of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy.

Compared To:

17% of people achieved SVR with pegylated-interferon and ribavirin alone ..

*Safety and tolerability results were consistent with prior Phase 3 studies-

The numbers in the SVR Delta column were obtained by subtracting the SVR rate in the control arm from the SVR rate in the Telaprevir arms
Control Arm= SOC pegylated-interferon and ribavirin alone

The links provided below give a comprehensive overview of both Telaprevir and Boceprevir with a summary of other HCV oral inhibitors.

Treatment of Hepatitis C in 2011

Hepatitis C Treatment : Boceprevir In Non-responders

Hepatitis C: Protease Pipeline

2010/Telaprevir/Boceprevir SVR all Trials *geno 1,2,3

"The Best of The Liver Meeting® State-of-the-Art-Lectures"

AASLD 2010 Summary Of Hepatitis C Oral Inhibitors

In case you missed it:
Watch The Video

A New Era of Hepatitis C Therapy: AASLD 2010

This coming new year will change the way we treat HCV. If you are interested in using these new agents now is the time to find the right doctor and start the process.

Please take the time to read this folks : Hepatitis C New Drugs:Telaprevir,Boceprevir Potential for Misuse Is ‘Huge’

The buzz is telaprevir should be available in the U.S. by spring and recently telaprevir was submitted to Europe.


What Happened In 2010?

HIV and Hepatitis Top Ten For 2010 .


From The Advocate

Top Ten News Stories about Hepatitis B

read about the news items that Christine Kukka, HBV Project Manager, ranked as the top news stories about HBV in 2010. . We would like to hear from our web site audience about what they believe are the top stories—take a very brief one page survey.


Newsletter: January 2011

HCV Advocate Top 10 News Items of 2010

A compilation of what we believed were the top ten stories of 2010. We judged telaprevir and boceprevir as the number one new story(s) of 2010, but the other items are in no particular order. We would like to hear from our web site audience about what they believe are the top stories—take a very brief one page survey .


In This Issue Of The HCV Advocate Newsletter:

Top 10 News of 2010

Alan Franciscus, Editor-in-Chief

HealthWise: Vitamin D and the Liver

Lucinda K. Porter, RN

HCV Snapshots

Lucinda K. Porter, RN

AASLD 2010: Part 2

Alan Franciscus, Editor-in-Chief


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